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NCT03509207 · OUTCOME

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Vorinostat (SAHA) in Uterine Sarcoma · Source last updated 2020-08-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
9 months

What was measured

This endpoint is evaluated by the amount of clinical adverse experiences.

Analysis population: Only one Patient reached the first end Point. Statistical Evaluation was therefore not possible. For this reason no data are reported in the data table.

Groups in this outcome

Vorinostat, Zolinza Oral Capsules

Vorinostat Oral Capsules 400mg daily Vorinostat Oral Capsule: Vorinostat, 400 mg orally once daily for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles. Patients with a response or stable disease after 4 cycles will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a period of 9 months.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Vorinostat, Zolinza Oral Capsules0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
This endpoint is evaluated by the amount of clinical adverse experiences.
groups
  1. description
    Vorinostat Oral Capsules 400mg daily Vorinostat Oral Capsule: Vorinostat, 400 mg orally once daily for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles. Patients with a response or stable disease after 4 cycles will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a period of 9 months.
    id
    OG000
    title
    Vorinostat, Zolinza Oral Capsules
population Description
Only one Patient reached the first end Point. Statistical Evaluation was therefore not possible. For this reason no data are reported in the data table.
reporting Status
POSTED
time Frame
9 months
title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
type
SECONDARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice